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Bowel Drugs Side Effects May Cause Fatal Blood Cancer: FDA Warns

  • Written by: Staff Writers
  • 5 Comments

Federal drug regulators are receiving an increasing amount of blood cancer reports from users of some drugs designed to treat inflammatory bowel disease (IBD)

The FDA issued a drug safety alert on April 14 for tumor necrosis factor (TNF) blockers, including Cimzia, Enbrel, Humira, Remicade and Simponi, as well as other types of drugs like azathioprine and mercaptopurine. The agency says a number of reports have linked the drugs to a rare cancer of white blood cells in children and young adults known as Hepatosplenic T-Cell Lymphoma (HSTCL).

The FDA has received 43 reports of HSTCL by patients who used TNF blockers, azathioprine or mercaptopurine, and the agency indicated that most of the cases involved patients treated with a combination of drugs that were known to suppress the immune system. However, the FDA also received reports of HSTCL from patients who were on azathioprine or mercaptopurine alone.

The drug most frequently connected to cases of HSTCL was Remicade, which was mentioned in 20 reports, but 18 of those patients were on either mercaptopurine or azathioprine as well. Azathioprine was the second most common drug mentioned in the reports. It was taken by 12 patients who were diagnosed with HSTCL.

Most of the cases involved patients being treated for ulcerative colitis and Crohn’s disease, both of which are forms of IBD. However there were at least two reports of patients who reported HSTCL after being treated for rheumatoid arthritis and one patient who was being treated for psoriasis.

HSTCL is a deadly cancer that affects the white blood cells and is highly aggressive; spreading quickly. The FDA urged health care professionals to carefully weigh the benefits of these drugs with their side effects.

Label warnings have already been updated for Remicade and Humira, and updates are in the process to warn consumers about the possible HSTCL side effects of azathioprine and mercaptopurine as well.

In 2009 the FDA required black box warnings be placed on all TNF blockers warning of the increased risk of childhood cancer. The FDA found that incidents of cancer began to appear about 30 months after TNF blocker treatment in some children being treated for juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disorder and Crohn’s disease.

According to the FDA’s Adverse Event Reporting System, between 1998 and 2008, approximately 30 children using Remicade, Enbrel and Humira reportedly developed cancer. About half of the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma. The other cancers included leukemia, melanoma and solid organ cancers. Some of those cases have been fatal.

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5 comments

  1. Steve Reply

    These cases of HSTCL need context. How many people take these drugs? What is the baseline rate of HSTCL in the general population? How about in the subpopulation of people who have IBD? All statistical, population-based based questions which really aren’t a very scientific way of understanding risk to individuals – but it is how FDA usually evaluates risk. FDA seems to acknowledges that people with IBD may develop this disease at a higher rate because of their IBD – but they don’t say hy they think that, or what they know about it. They also don’t present any scientific information. How well is the potential mechanistic connection between these drugs and HSTCL understood? Is development of the disease a probable effect of the drugs based on what we know about the drug mechanisms of action and what we know about the causes of the disease? In other words, is it reasonable to assume that an increased incidence of HSTCL would result from use of these drugs? Some cases of gastrointestinal disease (IBD) and other diseases treated with these drugs are quite serious and can even be fatal. It is not the article author’s fault that these facts are missing from the article. They are also missing from the FDA’s safety alert. So without context, how does the FDA’s safety alert helps patients and physicians decide to use, or not use, these drugs? If the risk of developing one case of HSTCL that would have occurred absent use of the drug, is one in 100, it’s very relevant to patient/physician decision making, but what if it is only one in 10,000 for all people taking these drugs? If one or more of these drugs is the only way a person can control his/her disease (and that is the case by the way), then a better sense of the relative risk is needed, so patients and physicians can weigh for themselves how to manage that risk against the risk of their disease. Come on FDA – what else do you know? If this is a small risk in the context of patient/physician decision making – tell us. If you only suspect there might be an increased risk, your alert should clearly explain that uncertainty. If you are sure there is an increased risk – your alert should explain that. This alert is about as helpful as telling us – 30 months from now lightning may strike the ground in some places. Is this a defensive knee jerk because you are getting reports without context – or is it an alert about a real risk. I think the FDA doesn’t know. So what should FDA do in a case like this? I think they should clearly state what they do, and don’t, know. If this is just a case of getting some adverse event reports so they are throwing an alert out there telling me they are getting adverse event reports, they are looking into it, they will let us know when they actually know if it is important, and they thought the public should know, that is what the alert should say, and it should be called something else – like an advisory. If they are really concerned, based on some level of usable data, that there is an increased risk from using this class of drugs – it should be called a safety alert, and they should tell us why they are concerned. This alert will cause some patients and physicians to stop using these drugs. For patients who need them – and won’t ever develop HSTCL (which is probably the large majority of them) is that a good public health outcome? Did FDA think about that? If they did, there is nothing in the safety alert about it. Bottom line FDA. It seems you are just covering your tail with this alert. How is this information useful for medical decision-making? That is your mission – protecting and promoting the public health – not just lobbing uncertainty into the mix so you can say later on you were on top of something, just in case it eventually turns out to be significant.

  2. Dani Reply

    Steve, thank you for your comment. I’ve been being treated with remicade for the past year and you basically typed out every thought in my mind right now. I’ve been going to other sites like crazy hoping they have more than this and I find nothing.

  3. Wanda Reply

    I was given fortunately only for a short period of time one of these drugs mecaptapurine. 15 years later, I am fighting a form of chronic anemia with no name yet cause I don’t have health insurance to assist in paying for the test. It cost me $10,000 to get blood, iron and see several physicians including a hematologist who could only explain for that amt of money that my blood cells were not shaped properly anymore. I have found doing my own research a glutathione acclerator that works inside the cells to detox (the drug) and repair the cells. This has given me a great deal of hope. When, I researched this subject 2 years, one year there was no info on the side effects. I think that yes the FDA is covering their but, but then again how can we make good decisions about drugs without some butt covering information, would I have taken the drug had I know the side effects years later?????? H**l no.

  4. Donald Reply

    I’ve used Humira for over 10 years for agressive Psoriatic arthritis. I used to be literally covered with psoriatic plagues and those literally disappeared within about 4 weeks of my first shot. I have of late been troubled by severe gastro distress in my lower bowels. Not Chrone’s, no celiac, nothing detectable as of yet, except that I’ve now noticed, and am now accurately tracking, that about 1 – 2 days after my Humira injection (which I typically do every 3 – 4 weeks), these distressing symptoms significantly abate. Hmmm.

    While all of these drugs present side effects, and with a very complex history that I am fighting, they still offer benefits that include, essentially, staying alive! I would have been very VERY dead if I had been born about 50 years earlier.

    The mass appeal of class action suits against folks like Abbot is appalling to me; seems many feel this is the way to make it through life. Where, pray tell, does it ever say you will get completely better, with absolutely no side effects, no interactions with all the other drugs you might be taking (in my case, about 12)?

    On the other hand, if Abbott, etc., were to simply say: “You might well have side effects for which we cannot fully control (given the unbelievable complexity of the human biochemical model), so sign here: that you understand its’ always a bit of a crap shoot, is life, and you are willing to try our wonder drug but that you are a mature adult, and in the event that it might well make things better for you but also have some negative side effect, including exacerbation of an existing condition, you have been reasonably warned!

  5. susan Reply

    My daughter has taken Mercaptopurine for 12 years since she was 9 years old for crohns disease and autoimmune hepatitis. This is a life sustaining medication for her. These new reports do concern me however I also know without this drug she most likely would not be here today. Untill a cure is found for these autoimmune illnesses the only thing one can do is stay informed talk to your doctors before making any decisions about starting or stopping any medications.

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